A Study to Learn More About the Safety of a Single Dose of BIIB144 and How it is Processed in the Body of Healthy Adult Participants Ages 18 to 55 Years Old as Compared to a Placebo
24 de julio de 2026 actualizado por: Biogen
A Phase 1, Randomized, Blinded, Placebo-Controlled, Single Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB144 in Healthy Adult Participants
In this study, researchers will learn how the body processes a study drug called BIIB144. This is a "first-in-human" study. This means that this study drug will be given to people for the first very time in this study. These studies are important because they help researchers learn about the safety of the study drug, how the body processes it, and what dose might be appropriate before testing it in larger groups.
The main goal of this study is to learn more about the safety of a single dose of BIIB144 compared to a placebo. A placebo is something that looks like the study drug but does not contain any medicine. A placebo is also given in the same way as the study drug.
The main question researchers want to answer in this study is:
How many participants have adverse events (AEs) and serious adverse events (SAEs)? An AE is a health problem that may or may not be caused by the study drug.
Researchers will also learn more about:
- How the body processes BIIB144 compared to placebo.
This study will be done as follows:
- Participants will be screened to check if they can join the study. The screening period will be up to 28 days, after which eligible participants will check into their study research center.
- Participants will stay at their study research center for about 8 days. Afterwards, they will have up to 13 visits to their study research center.
- This will be a "dose escalation" study. In this kind of study, increasing amounts of study drug are given to different groups of participants. Usually, this is done until researchers find the highest dose that does not cause harmful effects. In this study, the number of dose groups and maximum dose are planned in advance. The dose escalation will stop once these planned groups are done or if safety concerns arise.
- There will be a total of 6 groups. In each group, participants will receive a single dose of either BIIB144 or the placebo through an intravenous (IV) needle.
- Throughout the study, participants will give blood and urine samples. Participants will also have physical exams and answer questions about how they are feeling.
- Each participant will be in the study for up to 44 weeks.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
The primary objective of this study is to evaluate the safety and tolerability of IV administered ascending single doses of BIIB144 compared with placebo in healthy adult participants.
The secondary objective is to characterize the pharmacokinetics (PK) of IV administered ascending single doses of BIIB144 in healthy adult participants.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
48
Fase
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: US Biogen Clinical Trial Center
- Número de teléfono: 866-633-4636
- Correo electrónico: clinicaltrials@biogen.com
Copia de seguridad de contactos de estudio
- Nombre: Global Biogen Clinical Trial Center
- Correo electrónico: clinicaltrials@biogen.com
Ubicaciones de estudio
-
-
Nevada
-
Las Vegas, Nevada, Estados Unidos, 89113
- Reclutamiento
- Las Vegas Clinical Research Unit, PPD Development, LP
-
Contacto:
- Número de teléfono: 702-963-1600
-
Investigador principal:
- Aishwarya Vyas Lahar
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Sí
Descripción
Key Inclusion Criteria:
- Have a body mass index (BMI) between 18 and 32 kilograms per square metre (kg/m^2), inclusive, at Screening.
- Must be in good health as determined by the Investigator, based on medical history and Screening evaluations.
Key Exclusion Criteria:
- History of any clinically significant cardiac, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the Investigator.
- History of severe allergic or anaphylactic reactions, or of any allergic reactions that in the opinion of the Investigator are likely to be exacerbated by any component of the study treatment.
- History of, or ongoing, malignant disease, including solid tumors and hematologic malignancies (with the exception of basal cell carcinomas and squamous cell carcinomas that have been completely excised and considered cured at least 1 year prior to Day -1).
- History of, or positive test result at Screening for, human immunodeficiency virus (HIV).
- Any live or attenuated immunization or vaccination given within 14 days prior to Screening, between Screening and Day -1, or planned to be given during the study period.
Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: BIIB144 Cohort 1
Participants will receive Dose A of BIIB144 or a matching placebo via intravenous (IV) infusion on Day 1.
|
IV administrado
Administered IV
|
|
Experimental: BIIB144 Cohort 2
Participants will receive Dose B of BIIB144 or a matching placebo via IV infusion on Day 1.
|
IV administrado
Administered IV
|
|
Experimental: BIIB144 Cohort 3
Participants will receive Dose C of BIIB144 or a matching placebo via IV infusion on Day 1.
|
IV administrado
Administered IV
|
|
Experimental: BIIB144 Cohort 4
Participants will receive Dose D of BIIB144 or a matching placebo via IV infusion on Day 1.
|
IV administrado
Administered IV
|
|
Experimental: BIIB144 Cohort 5
Participants will receive Dose E of BIIB144 or a matching placebo via IV infusion on Day 1.
|
IV administrado
Administered IV
|
|
Experimental: BIIB144 Cohort 6
Participants will receive Dose F of BIIB144 or a matching placebo via IV infusion on Day 1.
|
IV administrado
Administered IV
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Periodo de tiempo: Up to Day 280
|
Up to Day 280
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Time of the Last Measurable Concentration (AUC0-last) of BIIB144
Periodo de tiempo: Pre-dose and at multiple time points post-dose up to Day 280
|
Pre-dose and at multiple time points post-dose up to Day 280
|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of BIIB144
Periodo de tiempo: Pre-dose and at multiple time points post-dose up to Day 280
|
Pre-dose and at multiple time points post-dose up to Day 280
|
|
Maximum Observed Serum Concentration (Cmax) of BIIB144
Periodo de tiempo: Pre-dose and at multiple time points post-dose up to Day 280
|
Pre-dose and at multiple time points post-dose up to Day 280
|
|
Time to Maximum Observed Serum Concentration (Tmax) of BIIB144
Periodo de tiempo: Pre-dose and at multiple time points post-dose up to Day 280
|
Pre-dose and at multiple time points post-dose up to Day 280
|
|
Terminal Elimination Half-Life (t½) of BIIB144
Periodo de tiempo: Pre-dose and at multiple time points post-dose up to Day 280
|
Pre-dose and at multiple time points post-dose up to Day 280
|
|
Total Body Clearance (CL) of BIIB144
Periodo de tiempo: Pre-dose and at multiple time points post-dose up to Day 280
|
Pre-dose and at multiple time points post-dose up to Day 280
|
|
Volume of Distribution During the Terminal Elimination Phase (Vz) of BIIB144
Periodo de tiempo: Pre-dose and at multiple time points post-dose up to Day 280
|
Pre-dose and at multiple time points post-dose up to Day 280
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Medical Director, Biogen
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
21 de julio de 2026
Finalización primaria (Estimado)
19 de junio de 2028
Finalización del estudio (Estimado)
19 de junio de 2028
Fechas de registro del estudio
Enviado por primera vez
18 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
18 de junio de 2026
Publicado por primera vez (Actual)
23 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
27 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
24 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 301HV101
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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